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Medline medical procedure convenience kits labeled as: KIT… recallZ-1090-2026 · Medline Industries, LP · initiated Dec 16, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medline Industries, LP or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.

FDA root cause category: Under Investigation by firm

What the company is doing

Medline Industries issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 12/16/2025 via email and USPS first class mail. The notice explained the issue, potential risk, and requested the following: "1.Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 2.Please use the link and the information below to complete your response form. Please list the quantityof affected product you have in inventory on the form. Even if you do not have any affected productin inventory, please complete and submit the form. Website link: https://recalls.medline.comRecall Reference #: R-25-145-FGX5 Recall Code: 3.Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. 4.If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected]."

Recall details

Recall number
Z-1090-2026
Status
Open, Classified
Initiated by the company
Dec 16, 2025
Posted by the FDA
Jan 14, 2026
Recalling firm
Medline Industries, LP
Quantity
12 units
Product code
OKV
Distribution
US Nationwide distribution.

Product description

Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G

Code information (models, lots, serial numbers)

UDI/DI 10198459156991 (EA) 40198459156992 (CS), Lot Number 25EBM426

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 98197).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page